ADHD DRUGS HAVE NEW WARNINGS

Published Online: Sunday, October 1, 2006

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Stimulants that are used to
treat attentiondeficit/hyperactivity
disorder
(ADHD) will have
stronger warning
labels, according
to an FDA mandate.
The labels
will warn against
the use of the medications in adults
or children with heart problems and
will notify physicians that they can
cause 1 child in 1000 to experience
hallucinations. The warnings will be
found on Adderall (Shire Pharmaceuticals
Group), Concerta
(McNeil Pharmaceuticals), and
Ritalin (Novartis).

Although these warnings are not
as strong as those approved earlier
this year by an FDA advisory committee,
they significantly strengthen
the risk information already on the
labels. The warnings are a result of
reports of sudden death in children
taking the drugs. In some reports,
the children were later determined
to have had structural defects of the
heart. The new warnings will
include, in part, "Sudden deaths,
strokes, and myocardial infarction
have been reported in adults taking
stimulant drugs at usual doses."